CROI 2020 Abstract eBook

Abstract eBook

Poster Abstracts

773 OBESITY, GESTATIONAL WEIGHT GAIN, AND ADVERSE BIRTH OUTCOMES IN SOUTH AFRICAN WOMEN Hlengiwe P. Madlala 1 , Thokozile R. Malaba 1 , Marie-Louise Newell 2 , Landon Myer 1 1 University of Cape Town, Cape Town, South Africa, 2 University of Southampton, Southampton, UK Background: HIV and/or ART may increase adverse birth outcomes including low birthweight (LBW) and small for gestational age (SGA) infants. In parallel, there are increasing concerns regarding obesity (BMI ≥30kg/m 2 ) in HIV+ individuals on ART; in pregnancy obesity is known to contribute to high birthweight (HBW) and large for gestational age (LGA) infants. However, there are few data on obesity and gestational weight gain (GWG) in HIV+ pregnant women on ART. Methods: We examined obesity and high GWG (>75thpercentile), and associations with birth outcomes in HIV+ (predominantly using TDF+XTC+EFC) and HIV- women in Cape Town. We consecutively enrolled 2828 pregnant women ages ≥18y at 1stantenatal visit. Follow-up was through routine medical records, with repeated GWG assessments available for the subset of 471 HIV+ women enrolled <=24 weeks gestation in an intensive study. Associations between obesity, high GWG and birth outcomes (birthweight and size for GA) were assessed via multinomial logistic regression adjusting for age, ART status, GA at enrolment and parity. Results: At 1st antenatal visit (median gestation, 19w), median BMI was 30 kg/m 2 (IQR, 26-35) in both HIV+ (36% of all participants) and HIV- women, with obesity prevalence of 49% and 50%, respectively. In the HIV+ subset, median GWG was 0.25 kg/week (IQR, 0.11-0.42); high GWG prevalence was 25%. In adjusted models, obesity in HIV- women was significantly associated with reduced risk of LBW (aOR 0.47, 95% CI 0.26-0.84) and SGA (aOR 0.51, 95% CI 0.32-0.82), and with increased risk of HBW (aOR 3.00, 95% CI 1.13-7.99) and LGA (aOR 2.13, 95% CI 1.28-3.55). In HIV+ women, obesity was also significantly associated with reduced risk of LBW (aOR 0.43, 95% CI 0.23-0.80) and SGA (aOR 0.59, 95% CI 0.35-0.99), and non-significantly with increased risk of HBW (aOR 1.30, 95% CI 0.46-3.65) and LGA (aOR 1.34, 95% CI 0.73-2.48). In the HIV+ subset, high GWG was associated with increased risk of HBW (aOR 4.51, 95% CI 1.67-12.15) and LGA (aOR 2.52, 95% CI 1.13-5.59). Conclusion: Obesity in pregnancy and high GWG are prevalent in this setting in both HIV+ and HIV- women. High GWG in HIV+ women was associated with increased risk of HBW and LGA, while obesity was associated with reduced risk of LBW and SGA. Outcomes of HIV+ women may now parallel those of HIV- women.

study was then done to identify risk factors. Women with a positive OGTT were matched to controls based on HIV status and age in a 1:4 ratio. Prevalence of GDM was compared by HIV status with Fisher’s exact test. Demographics were compared between cases and matched controls via chi- square or Mann-Whitney U test. Univariate and multivariate logistic regression was used to determine factors associated with GDM. Results: Among enrollees, 11 (13.9%) of 79 HIV+ and 10 (6.5%) of 155 HIV- had GDM (p=0.06). In the case control study of the 21 GDM and 74 matched non-GDM controls, median pre-pregnancy BMI was 21.7 kg/m 2 (IQR 19-24.2). Median CD4 in HIV was 420 cells/mm 3 , 5 (1.1%) were on protease-inhibitor (PI)-based antiretroviral therapy (ART), and 37 (82%) were on NNRTI-based ART. Weight (54.3 vs 48.9 kg, p=0.02) at study entry, MUAC (26.4 vs 23.7 cm, p=0.04) at study entry, and pre-pregnancy BMI (24.1 vs 21.2 kg/m 2 , p=0.00) was significantly higher among cases than controls. Among HIV+, weight at study entry and 3rdtrimester, MUAC at study entry and 3rdtrimester, and pre- pregnancy BMI were significantly higher among cases than controls. Among HIV-, only pre-pregnancy BMI was significantly higher. Use of PIs showed a trend toward significant association. Conclusion: In our study of pregnant women in India, HIV+ women had a higher prevalence of GDM than HIV- women, which was incompletely explained by PI use. Higher MUAC, weight, and BMI were associated with increased risk of GDM among HIV+ but not HIV-participants. Ongoing studies are identifying the pathogenesis behind this increased risk. 775 CABOTEGRAVIR PHARMACOKINETIC TAIL IN PREGNANCY AND NEONATAL OUTCOMES Parul Patel 1 , Shanker Thiagarajah 2 , Susan Ford 3 , David A. Margolis 1 , Beth H. Romach 1 , Mark Baker 4 , Kenneth Sutton 1 , Conn M. Harrington 1 , Mark S. Shaefer 1 , William Spreen 1 , Kimberly Smith 1 , Vani Vannappagari 1 1 ViiV Healthcare, Research Triangle Park, NC, USA, 2 GlaxoSmithKline, Uxbridge, UK, 3 GlaxoSmithKline, Research Triangle Park, NC, USA, 4 ViiV Healthcare, Nyon, Switzerland Background: Cabotegravir (CAB) is a long-acting (LA) HIV integrase inhibitor in Phase 3 development for HIV treatment in combination with rilpivirine LA, and as monotherapy for HIV prevention. Injectable CAB LA, given monthly or every 2 months, maintains plasma concentrations that may persist for a year or longer following discontinuation. Nonclinical reproductive toxicology studies of CAB have not identified a birth defect risk at supratherapeutic exposures. We evaluated CAB pharmacokinetics (PK) in HIV-infected women becoming pregnant and neonatal outcomes to date in ViiV-Sponsored trials. Methods: As of December 7, 2018, ≥ 594 HIV-infected or un-infected females of reproductive potential have been exposed to ≥1 dose of CAB (oral/LA) through Phase 3 in ViiV-sponsored clinical trials. Per protocol, CAB troughs were obtained pre-injection with dosing discontinued upon pregnancy detection, however PK sampling continued quarterly for 52 weeks after last injection. Available CAB PK collected pre-pregnancy and during long term follow-up to evaluate the PK tail during pregnancy, delivery, and post-partumwere summarized with birth outcomes. Results: Thirteen pregnancies were reported during CAB dosing (4 oral CAB; 9 CAB LA), 4 resulting in live births (1 in DAIDS HPTN077 study; conception post CAB LA discontinuation), 5 terminated electively, and 4 with miscarriage in first 9 weeks of gestation. No cases of birth defects have been reported. Three HIV- infected women receiving CAB LA 400mg IMmonthly injections (range: 16-176 weeks on therapy) became pregnant with subsequent live birth outcomes. All were virologically suppressed with pre-dose CAB concentrations of 2.41-4.63 µg/mL just prior to pregnancy and 2.10-5.04 µg/mL at time of pregnancy confirmation. Following CAB LA discontinuation, residual CAB concentrations remained measurable throughout pregnancy with a predicted concentration of ~0.5 µg/mL(3x PA-IC 90 [0.166 µg/mL]) at delivery and remaining detectable post-partum (range: 2-23 weeks) in 2/3 women.These data are consistent with absorption-rate limited PK. Conclusion: Pre-pregnancy CAB trough concentrations were consistent with population estimates for monthly dosing and declined slowly following drug discontinuation in pregnancy with predicted concentration 3x PA-IC 90 at time of delivery in 2 of 3 HIV-infected women with live birth outcomes. CAB PK tail in pregnancy was within the expected range for non-pregnant women. Pregnancy surveillance in the treatment and prevention program continues.

Poster Abstracts

774 FACTORS ASSOCIATED WITH GESTATIONAL DIABETES IN HIV+ AND HIV– WOMEN IN PUNE, INDIA Puja Chebrolu 1 , Mallika Alexander 2 , Ramesh Bhosale 3 , Shilpa Naik 3 , Nikhil Patil 2 , Amita Gupta 2 , Jyoti S. Mathad 1 1 Weill Cornell Medicine, New York, NY, USA, 2 Johns Hopkins University, Baltimore, MD, USA, 3 Byramjee Jeejeebhoy Government Medical College, Pune, India Background: HIV is associated with an increased risk of diabetes, but its association with gestational diabetes (GDM) is still debated. We undertook this study to investigate the prevalence of GDM among HIV+ and HIV- pregnant women and its associated risk factors in each group. Methods: From 2016 to 2019, we conducted a prospective, longitudinal cohort study designed to characterize the effects of pregnancy on the immune response to M. tuberculosis (PRACHITi) in Pune, India. The study enrolled HIV+ and HIV- pregnant women in their 2nd trimester and followed them through 1 year postpartum. All women were screened with the WHO-recommended oral glucose tolerance test (OGTT), to diagnose GDM. We identified the prevalence of GDM in HIV+ and HIV- women among the whole cohort. A case-control

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